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Draft Guidance for Industry: Action Level for Arsenic in Apple Juice July 2013


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

This draft guidance document provides information to manufacturers on the action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 

Arsenic is an element that occurs in the environment from both natural and anthropogenic sources including erosion of arsenic-containing rocks, volcanic eruptions, contamination from mining and smelting ores, and previous or current use of arsenic-containing pesticides (Ref. 1). Arsenic is found in both inorganic and organic forms (together referred to as total arsenic), and inorganic arsenic is generally considered more toxic than organic arsenic (Ref. 2). Consumption of inorganic arsenic has been associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans (Ref. 2). In recent assessments, the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives (JECFA) (Ref. 2), which includes participation by U.S. FDA scientists, concluded that food can be a major contributor to inorganic arsenic exposure, and the European Food Safety Authority (EFSA) (Ref. 3) concluded that dietary exposure to inorganic arsenic should be reduced. These findings suggest a need to reduce exposure to inorganic arsenic from food. 

Download the Draft Guidance

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0322.

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